Model Number 03.505.003 |
Device Problem
Break (1069)
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Patient Problem
Unspecified Tissue Injury (4559)
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Event Date 03/18/2021 |
Event Type
Injury
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Manufacturer Narrative
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Additional product code: dzi, dzj.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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It was reported on (b)(6) 2021 that during a rib plating and orif procedure of ulnar fracture from a mva, that the device used to secure screws came apart vs failed at the end of the procedure for rib plating.Device representative called to notify and advised.The primary surgeon that is well familiar with the device.He had been using it for 8 years and actually tried the device when in (b) (6).The operating room felt all pieces were accounted for and nothing was found in thoracic cavity.The second surgeon completed the orif of ulna.Chest x-ray was ordered after closure of both procedure to confirm chest tube placement and lung status.The x-ray showed a significant foreign object in subcutaneous tissue.Surgeon was notified patient had reopened surgery for removal of rfo.Patient was not removed from the operating room and was not extubated from the initial procedure.This (b)(4) captures the event "the device used to secure screws came apart vs failed at the end of the procedure for rib plating" intraoperatively while (b)(4) captures the re-opening of the patient due to the removal of the foreign body object post-operatively.This report is for one (1) shaft for 90° screwdriver.This is report 2 of 2 for complaint (b)(4).
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Event Description
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The rib plating was successfully completed and the screws were secured.The procedure was delayed an unknown number of minutes.
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: b5, h6.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: the device was not returned for investigation.It cannot be confirmed that the screw driver shaft broke into two pieces intra-operatively as there were no available information documenting the issue and all the sub-components appears to be disassembled post-surgery.A definitive root cause cannot be determined from the information provided.A manufacturing record evaluation cannot be done as there is no available lot information.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/ specification review were not completed.Conclusion: the complaint condition cannot be confirmed based on the image provided.During the investigation, no product design issues, or discrepancies were observed.No manufacturing issues were noted during investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.Device history review: dhr review could not be performed as there was no lot number information available for the part.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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Rib plating was successfully completed.There was a delay of an unknown length while the patient was reopened to retrieve the item.The orif for ulnar fracture was also successfully completed with no issues.It was noted the post-operative course was uncomplicated and the patient was discharged in stable condition.
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Search Alerts/Recalls
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